22 March 2021

CEO Update | Monday 22 March

Positive UK manufacturing news

FUJIFILM Corporation is investing $83m to expand microbial production capacity of FUJIFILM Diosynth Biotechnologies in the UK. This will triple the plant’s current capacity of microbial production and it is fantastic to see an established international player like FUJIFILM making such a significant investment in its manufacturing capability in this country. This follows last week’s news that Touchlight and eXmoor pharma had received significant investment, and GSK announcing plans to accelerate its cell and gene therapy pipeline for clinical trials. The momentum in UK advanced medicine manufacturing is tremendously encouraging. It was great to see Vaccitech, an Oxford start-up behind the Oxford/AstraZeneca COVID-19 vaccine, complete a $168m Series B financing round to advance their clinical programs. Vaccitech is aiming to address global public health challenges in both infectious disease and cancer with their T cell inducing immunotherapy platform.

We also saw positive news for the UK’s ATMP sector with the announcement that three new Gene Therapy Innovation Hubs, funded by LifeArc, the Medical Research Council (MRC), and the Biotechnology and Biological Sciences Research Council (BBSRC) are to open. The dedicated facilities at Kings College London, NHS Blood and Transplant Bristol, and Sheffield University will facilitate clinical trials of novel gene therapies helping innovative research to reach patients.

 

COVID-19 vaccines

It was good to see the initial trial data from the USA on the safety and efficacy of the Oxford/AstraZeneca vaccine. While attention this side of the Atlantic focused on COVID-19 vaccine safety, I was pleased to see that the in-depth review by the EMA (working closely with other health authorities including the MHRA), found that the Oxford/AstraZeneca vaccine is safe and effective. I’m glad that the EMA’s review process was able to benefit from the experience of the UK regulator which has overseen the administration of this vaccine to around 11 million people. This shows the scientific and patient benefits of continued close co-operation in the post-Brexit regulatory landscape.

 

Updated guidance for batch testing

On Tuesday the MHRA updated its guidance on the acceptance of batch testing conducted in EEA countries. Previously this would have ceased to be accepted from 1 January 2023. Now, an evidence-based review will be conducted to determine the future of batch testing in the UK. New arrangements will be determined by the end of 2022 and there will be a two-year grace period before any new batch testing arrangements come into force. This change in guidance follows continued advocacy by the BIA and the broader life sciences sector, including the provision of evidence and case studies from BIA member companies. We look forward to working closely with the Government and companies to shape this review.

 

Life Sciences in Parliament

This week we are starting to see more detail of the Government’s plans for the new Advanced Research and Invention Agency (ARIA). The Government has now published the design principles and research focus and the Bill introducing the new agency will be in Parliament this week. Last Wednesday, Boris Johnson’s former Chief of Staff, Dominic Cummings gave evidence on ARIA to the Science and Technology Select Committee. Looking beyond the immediate headlines, it was interesting to hear him highlight the UK’s strength in life sciences and that genomics in particular could be a key focus of ARIA. He also said that the Vaccines Taskforce and Venture Capital offer prime examples of how ARIA should operate. Many of these comments echo the BIA’s own view on the new agency - stay tuned for more news on our approach to ARIA in the coming weeks.

Also on Wednesday, Daniel Zeichner MP, Chair of the All-Party Parliamentary Group (APPG) for Life Sciences, led a Westminster Hall debate on the future of R&D funding. Following briefings by the BIA, both Zeichner and his Cambridge neighbour Anthony Browne MP highlighted that the life sciences sector is consistently the largest R&D investor in the UK and commented on the sector’s key role in providing solutions to the pandemic. They both called on the Government as a matter of urgency to relaunch the Biomedical Catalyst with a significant budget to ensure that this successful funding programme continues to support early-stage biotech companies and SMEs.

 

PULSE

Our annual programme for up-and-coming life sciences entrepreneurs, PULSE, took place over three days last week, in partnership with the Francis Crick Institute. Aspiring entrepreneurs were involved in a mix of interactive exercises and networking opportunities to equip attendees with the information and inspiration to become leading CEOs and entrepreneurs in our sector. Take a look at blogs from previous PULSE candidates to find out more about their experiences.

 

Upcoming events

I am looking forward to attending the BIA’s Scottish regional event taking place this Wednesday. Companies in Glasgow are at the forefront of the new digital approach to drug discovery, development, and manufacturing so I am keen to hear more from DeepMatter, CMAC, and the Medicines Manufacturing Innovation Centre. Find out more and register here.

Another event which may be of interest to members is the latest webinar in Deloitte’s Life Sciences Catalyst events programme ‘Advancing Innovation from Abroad: Investing in Life Sciences in China and the UK’. The webinar will provide information on the Chinese life sciences industry with panellists from the East of England China forum, TusPark Holdings, and AstraZeneca’s I-Campus. Register here.

Best,

Related topics